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CompletedNCT04856527Updated Aug 21, 2024Results posted

Motor Control Physical Therapist Support Stroke

An interventional study of Physical therapist support in Stroke, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by University of Cincinnati · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to systematically determine the effect of unnecessary physical therapist assistance in individuals after stroke during the practice of an upper limb task on an individual's task performance and their underlying motor control patterns when learning (or re-learning) motor skills.

Read the detailed description

Independent motor task performance is the most highly prioritized outcome of physical therapy for individuals with motor disability. Accordingly, a key priority for physical therapists in multiple practice settings is the advancement of functional motor independence. Therapists must determine when a patient requires assistance (e.g., verbal cues, physical support) to complete a motor task and when a patient is able to execute a motor skill with less assistance. If a therapist does not provide enough support, the patient is at risk for unsuccessful task performance. As such, therapists often default to providing a higher level of assistance.

An individual following stroke, for instance, may demonstrate an increased magnitude of postural sway while completing self-care activities at the sink. A therapist may decide to provide physical support for the patient to decrease sway variability, whether or not the patient requires this support to maintain performance. The motor control consequences of providing this assistance (thus constraining movement variability and providing fewer options for adapting movement) when assistance is actually not needed is unknown. The purpose of this study is to systematically determine the effect of unnecessary assistance during the practice of an upper limb task on functional performance and underlying motor control patterns when learning (or re-learning) motor skills in individuals with stroke. The insights gained from the current project will have the potential to improve the currently available physical therapy interventions for individuals with stroke.

The effects of unnecessary physical therapist support will be examined in terms of upper limb task performance, retention, and transfer, and in terms of the postural control supporting task performance. The study is currently planned for individuals with stroke. Participants will be required to maintain the position of a virtual laser within a target while standing. An experimental group will receive postural support (physical assistance to maintain upright posture) during a practice period in order to specifically determine the effect of postural support on upper limb task performance and postural sway patterns. Participants will also engage in a light finger force production transfer task to ascertain the influence of postural support on a different supra-postural task.

It is hypothesized that providing unnecessary assistance (and thus limiting independence) during practice of a novel motor task will result in (a) faster improvements in task performance but reduced retention and more limited transfer to another, similar task; and (b) reduced task- sensitive postural sway adjustments (measured in terms of both the quantity and temporal structure) during practice, at transfer, and at retention, reflecting reduced adaptability of postural patterns to task demands.

02

Conditions studied

  • Stroke

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Keywords

  • physical therapy
  • postural control
  • supra-postural task
  • stroke
  • motor control
  • contextual factors
  • variability
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 25 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Between 45 and 80 years at time of consenting
  2. Previous diagnosis of stroke for which they sought treatment (> 1 month prior to enrollment)
  3. Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
  4. Independence or modified independence during ambulation (defined as the ability to ambulate with no physical assist and walk with an assistive device as needed) for at least 30 ft.
  5. Score 0-3 on the Modified Rankin Scale, which indicates complete independence to moderate disability but able to walk without assistance.
  6. Maintain standing balance for > 2 minutes with no physical support.
  7. Maintain grasp of a handheld object with at least one hand.

Exclusion criteria

Exclusion Criteria:

  1. Limited language abilities, deafness, blindness, or serious motor impairment that outright prevents performance of the experimental tasks (e.g., severe lower extremity spasticity)
  2. Pregnancy.
  3. Pain with weightbearing > 4/10.
  4. Inability to answer consent questions and follow simple 1-step commands.
  5. Any other medical condition that would preclude the valid administration of the study measures, specifically seizure disorders or additional neurologic conditions beyond stroke.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Experimental Group

    Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.

    Behavioral: Physical therapist support

  • No intervention
    Control Group

    Participants will receive no physical therapist support while completing the task.

Interventions

  • BehavioralPhysical therapist support

    Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.

06

What researchers measure

Primary outcomes

  1. Center of Pressure Path Length

    The amount of displacement of the location of the (resultant) vertical ground reaction force vector. Results only presented as the mean difference between groups, as only the paretic limb was used for this portion of the study. There are no results to report for the non-paretic limb.

    Time frame: 10 minutes of practice

  2. Standard Deviation of Center of Pressure

    Variability of center of pressure trajectory.

    Time frame: After 10 minutes of practice

  3. Percent Determinism of Postural Sway

    Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space. Highter values of percent determinism indicate more regularity in postural sway.

    Time frame: After 10 minutes of practice

  4. Entropy (Sample Entropy)

    Evaluates the predictability of the next state of a system, given what is known about the current state of a system. Higher values of SampEn indicate less regularity; lower values indicate more regularity. Outcome measure reported as a ratio of anterior-posterior to medial-lateral SampEn values.

    Time frame: After 10 minutes of practice

  5. Percent Correct

    Percent time on target.

    Time frame: After 10 minutes of practice

07

Results

Posted Aug 21, 2024

Participant flow

Participant flow — Overall Study
MilestoneExperimental GroupControl Group
Started1312
Completed1112
Not completed20
Withdrew: Unable to complete experimental task20

Outcome measures

PrimaryCenter of Pressure Path Length

The amount of displacement of the location of the (resultant) vertical ground reaction force vector. Results only presented as the mean difference between groups, as only the paretic limb was used for this portion of the study. There are no results to report for the non-paretic limb.

Time frame:
10 minutes of practice
Reported as:
Mean · cm^2
Center of Pressure Path Length
cm^2Experimental GroupControl Group
Center of Pressure Path Length98.5 ± 17.5156.1 ± 16.8
PrimaryStandard Deviation of Center of Pressure

Variability of center of pressure trajectory.

Time frame:
After 10 minutes of practice
Reported as:
Mean · cm
Standard Deviation of Center of Pressure
cmExperimental Group: Paretic LimbControl Group: Paretic LimbExperimental Group: Non-Paretic LimbControl Group Non-Paretic Limb
Standard Deviation of Center of Pressure.70 ± .06.53 ± .05.69 ± .04.53 ± .04
PrimaryPercent Determinism of Postural Sway

Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space. Highter values of percent determinism indicate more regularity in postural sway.

Time frame:
After 10 minutes of practice
Reported as:
Mean · percent determinism
Percent Determinism of Postural Sway
percent determinismExperimental Group: Paretic LimbControl Group: Paretic LimbExperimental Group: Non-Paretic LimbControl Group: Non-Paretic Limb
Percent Determinism of Postural Sway.99 ± .001.99 ± .001.99 ± .001.99 ± .001
PrimaryEntropy (Sample Entropy)

Evaluates the predictability of the next state of a system, given what is known about the current state of a system. Higher values of SampEn indicate less regularity; lower values indicate more regularity. Outcome measure reported as a ratio of anterior-posterior to medial-lateral SampEn values.

Time frame:
After 10 minutes of practice
Reported as:
Mean · ratio of AP:ML
Entropy (Sample Entropy)
ratio of AP:MLExperimental Group: Non-Paretic LimbControl Group: Non-Paretic LimbExperimental Group: Paretic LimbControl Group: Paretic Limb
Entropy (Sample Entropy)1.2 ± .191.54 ± .181.4 ± .181.1 ± .19
PrimaryPercent Correct

Percent time on target.

Time frame:
After 10 minutes of practice
Reported as:
Mean · percentage of time on target
Percent Correct
percentage of time on targetExperimental Group: Paretic LimbControl Group: Paretic LimbExperimental Group: Non-Paretic LimbControl Group: Non-Paretic Limb
Percent Correct.66 ± .08.74 ± .06.95 ± .01.91 ± .01

Adverse events

Collected over No adverse events occurred during the study (1 hour, single session). Participants were only assessed for adverse events during the 1-hour single session. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental Group0/11 (0%)0/11 (0%)0/11 (0%)
Control Group0/12 (0%)0/12 (0%)0/12 (0%)
Most frequent other events
Most frequent other events
EventExperimental GroupControl Group
FallMusculoskeletal and connective tissue disorders0/110/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)Experimental GroupControl GroupTotal
Mean57 ± 4.350.8 ± 8.453.7 ± 7.3
Sex: Female, Male
Sex: Female, Male(Participants)Experimental GroupControl GroupTotal
Female71017
Male426
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Experimental GroupControl GroupTotal
Hispanic or Latino000
Not Hispanic or Latino111223
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental GroupControl GroupTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American4711
White7512
More than one race000
Unknown or Not Reported000
08

Study locations

1 site
  • University of Cincinnati Center for Cognition, Action, and Perception
    Cincinnati, Ohio 45221, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 7, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Analytic code and other study materials may be shared on PI's Open Science Framework (OSF) page.

Supporting information: Analytic code

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04856527
Lead sponsor
University of Cincinnati
Collaborators
TriHealth Inc.
Responsible party
Sarah Schwab (Principal Investigator, University of Cincinnati) — Principal investigator
First posted
Apr 23, 2021
Start date
Jun 2, 2021
Primary completion
Oct 12, 2021
Completion
Oct 12, 2021
Results posted
Aug 21, 2024
Last update
Aug 21, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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